Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-26 @ 3:39 PM
Study NCT ID:
NCT00501358
Status:
UNKNOWN
Last Update Posted:
2007-07-16
First Post:
2007-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Apnea and Tromboembolic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'lastUpdateSubmitDate': '2007-07-13', 'studyFirstSubmitDate': '2007-07-13', 'studyFirstSubmitQcDate': '2007-07-13', 'lastUpdatePostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-16', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SLEEP APNEA', 'venous thromboembolism', 'COAGULABILITY', 'COAGULATION FACTORS', 'HYPOXIA'], 'conditions': ['Sleep Apnea Syndromes', 'Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'There is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (SAHS), which could play a role in the increased cardiovascular morbility and mortality. Respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be a risk factor for venous thromboembolism (VTE).\n\nOBJECTIVES:To calculate and compare the prevalence of sleep apnea-hipopnea syndrome in patients with venous thromboembolism with a gender, aged and BMI matched control group. Assessment of the association between SAHS and other risk factors for VTE. To compare clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial obstruction index in patients with SAHS and VTE and those ones without SAHS.', 'detailedDescription': 'DESIGN: Case-control study.\n\nMETHODS: 133 SAHS patients and 133 controls will be studied. The study includes:\n\na) medical history; b) anthropometric variables (weight, height, body mass index, Mallampati index); c) sleepiness tested by Epworth scale; d) London Chest Activity of Daily Living Scale; e) conventional polysomnography (PSG); f) testing: clotting-fibrinolisis factors (factor V, VII, VIII; C and S protein, plasminogen tissular activator (t-PA) and inhibitor of plasminogen activator (PAI-1); g) d-dimer and thrombin-antithrombin III complex; h) basic biochemical profile and hemograma; i) Pulmonary artery obstruction index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Case group:\n* Pulmonary embolism diagnosed by CT Pulmonary Angiography.\n* Control group:\n* randomly selected from among patients in two primary health care centers in Mallorca without tromboembolic disease\n\nExclusion Criteria:\n\n* Refusal to sign informed consent.\n* Expected survival less than 12 months\n* Long-term oxygen therapy\n* Hospital admission in the previous two months.\n* Familiar thrombophilia'}, 'identificationModule': {'nctId': 'NCT00501358', 'briefTitle': 'Sleep Apnea and Tromboembolic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Sociedad Española de Neumología y Cirugía Torácica'}, 'officialTitle': 'Assessment of Sleep Apnea Syndrome as a Risk Factor for Venous Thromboembolism', 'orgStudyIdInfo': {'id': 'TEP-SAHS'}}, 'contactsLocationsModule': {'locations': [{'zip': '07014', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Son Dureta', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}], 'centralContacts': [{'name': 'Alberto Alonso, MD', 'role': 'CONTACT', 'email': 'aalonso@hsd.es', 'phone': '0034971175112'}], 'overallOfficials': [{'name': 'Alberto Alonso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sociedad Española de Neumología y Cirugía Torácica'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sociedad Española de Neumología y Cirugía Torácica', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Caubet-Cimera Islas Baleares', 'class': 'OTHER'}]}}}